Study highlights the clinical performance of NIS4® technology in diagnosing at-risk NASH in patients with type 2 diabetes irrespective of age compared to other non-invasive tests
New analyses show the potential of NIS4® technology to be a valuable clinical tool either alone or in sequential combination with other blood-based non-invasive tests in identifying at-risk NASH and advanced fibrosis in patients with and without type 2 diabetes
Key Opinion Leaders highlight the potential for non-invasive tests in the diagnosis of at-risk NASH on ADA TV
Lille, France; Cambridge, MA; June 23, 2021 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases, today announced it will be making two poster presentations at two internationally-renown scientific and medical events in June 2021, including a thought-leadership documentary featuring Key Opinion Leaders (KOLs).
A poster presentation looking at the effects of age on the clinical performance of GENFIT’s proprietary diagnostic technology NIS4® in diagnosing at-risk NASH in patients with type 2 diabetes in comparison to a number of non-invasive tests, will be presented at the International Liver Congress™ 2021 on June 23-26, 2021, organized by the European Association for the Study of the Liver (EASL).
A poster presentation providing key insights into the performance of NIS4® technology either alone or in combination with other blood-based non-invasive tests in identifying at-risk NASH and advanced fibrosis in patients with and without type 2 diabetes, will be presented at the 81st Scientific Sessions of the American Diabetes Association (ADA) on June 25-29, 2021.
In addition, GENFIT is a key contributor to a thought-leadership documentary for ADA TV discussing, alongside KOLs, the link between NASH and patients with type 2 diabetes and how access to non-invasive diagnostic test kits to diagnose NASH, such as NASHnext™, powered by GENFIT’s NIS4® technology, could provide an alternative to costly and invasive procedures and potentially benefit millions of patients. Featured KOLs include:
Dr. Fernando Bril, Endocrinologist, University Alabama-Birmingham School of Medicine (Birmingham, Alabama)
Dr. Stephen Harrison, Gastroenterologist/Hepatologist, Medical Director at Pinnacle Research (San Antonio, Texas)
Dr. Suneil Hosmane, GENFIT (Cambridge, Massachusetts)
Dr. Brian Cavaney, CMO, Labcorp (Burlington, North Carolina)
Donna Cryer, President and Founder of the Global Liver Institute (Washington, DC)
To view the 5-minute thought-leadership documentary, please click on the following link: https://www.youtube.com/watch?v=MlBoAG5tFMEv
International Liver Congress™ June 23-26, 2021
Title: In Type 2 Diabetic Patients, the Identification of At-risk Nash is Impacted by Age: A Comparison of Serum-Based NITS Including NIS4®
Abstract number: 2739
Poster identifier: PO-2739
Authors: Vlad Ratziu, Jeremy Magnanensi, Sylvie Deledicque, Elodie Delecroix, Yacine Hajji, Christian Rosenquist, Suneil Hosmane and Arun Sanyal.
81st Scientific Sessions of the ADA
Title: Application of NIS4® Technology for Stand-alone and Sequential Identification of At-risk NASH or Advanced Fibrosis in Non-Diabetic and Type 2 Diabetic Patients
Abstract number: #2021-A-5594-Diabetes
Poster number: 1174-P (Category 21-C Integrated Physiology—Liver)
Authors: Christian Rosenquist, Yacine Hajji, Jérémy Magnanensi, Nicolas Stankovic-Valentin, Suneil Hosmane and Arun J. Sanyal
ABOUT THE INTERNATIONAL LIVER CONGRESS™
The International Liver Congress™ is an annual congress and EASL’s flagship event, attracting scientific and medical experts from around the world to learn about the latest in liver research.
ABOUT THE ADA
The ADA is the US’ leading voluntary health organization fighting to bend the curve on the diabetes epidemic and help people living with diabetes thrive. It holds annual scientific sessions to bring together the latest, cutting-edge advances in diabetes research, prevention and care.
NIS4® is GENFIT’s non-invasive, blood-based diagnostic technology, which was developed to identify patients with non-alcoholic steatohepatitis (NASH) and significant to advanced fibrosis (F>2), also referred to as at-risk NASH. In January 2019, GENFIT signed a licensing agreement with Labcorp® to make NIS4® technology available for use in clinical research through their drug development subsidiary, Covance. In September 2020, GENFIT signed another licensing agreement with Labcorp to commercialize NIS4® in the US and Canada as a Laboratory Developed Test. Since April 2021, Labcorp has made NASHnext™, powered by NIS4®, available for use in the clinic. GENFIT also continues to explore opportunities to obtain formal marketing authorization of an in vitro diagnostic (IVD) test supported by NIS4® technology in both the U.S. and European markets. For more information, please visit: https://nis4.com.
NASH is a liver disease characterized by an accumulation of fat (lipid droplets), along with inflammation and degeneration of hepatocytes. The disease is associated with an increased risk of cardiovascular disease along with long-term risk for progression to cirrhosis, leading to liver insufficiency and potential progression to liver cancer. NASH is a serious disease that often carries no symptoms in its early stages, but if left untreated can result in cirrhosis, cancer, and the need for liver transplant. The prevalence of NASH is rapidly increasing as a result of the growing obesity and diabetes epidemics and is believed to affect as much as 12 percent of people in the U.S. and six percent worldwide.
GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with cholestatic and metabolic chronic liver diseases. GENFIT is a pioneer in the field of nuclear receptor-based drug discovery, with a rich history and strong scientific heritage spanning more than two decades. GENFIT is currently enrolling in ELATIVE™, a Phase 3 clinical trial evaluating elafibranor in patients with Primary Biliary Cholangitis (PBC). Elafibranor is an investigational compound that has not been reviewed and has not received approval by any regulatory authority. As part of GENFIT’s comprehensive approach to clinical management of patients with liver disease, the Company is also developing NIS4®, a new, non-invasive blood-based diagnostic technology which could enable easier identification of patients with at-risk NASH. GENFIT has facilities in Lille and Paris, France, and Cambridge, MA, USA. GENFIT is a publicly traded company listed on the Nasdaq Global Select Market and on compartment B of Euronext’s regulated market in Paris (Nasdaq and Euronext: GNFT). www.genfit.com
GENFIT FORWARD LOOKING STATEMENTS
This press release contains certain forward-looking statements with respect to GENFIT, including those within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the performance of NIS4® technology in the detection of NASH and at-risk NASH in non-diabetic and type 2 diabetic patients, the performance of NIS4® technology relative to other technologies, the potential for diagnostic tests powered by NIS4® technology to play a critical role in the diagnosis and management of patients with NASH, the potential for non-invasive testing to gain importance and the capability of NIS4® technology to identify patients who may require medical intervention, the development plans for NIS4® in the U.S. and in Europe and timing of such development plans, and the potential to obtain formal marketing authorization of an IVD test supported by NIS4® technology in the U.S. and/or European markets. The use of certain words, including “consider”, “contemplate”, “think”, “aim”, “expect”, “understand”, “should”, “aspire”, “estimate”, “believe”, “wish”, “may”, “could”, “allow”, “seek”, “encourage” or “have confidence” or (as the case may be) the negative forms of such terms or any other variant of such terms or other terms similar to them in meaning is intended to identify forward-looking statements. Although the Company believes its projections are based on reasonable expectations and assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including in relation to safety, biomarkers, progression of, and results from, its ongoing and planned clinical trials, review and approvals by regulatory authorities of its drug and diagnostic candidates, exchange rate fluctuations and the Company’s continued ability to raise capital to fund its development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the French Autorité des Marchés Financiers (“AMF”), including those listed in Chapter 2 “Main Risks and Uncertainties” of the Company’s 2020 Universal Registration Document filed with the AMF on 23 April 2021 under n° D.21-0350, which is available on the Company’s website (www.genfit.com) and on the website of the AMF (www.amf-france.org) and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”) including the Company’s 2020 Annual Report on Form 20-F filed with the SEC on April 23, 2021. In addition, even if the Company’s results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this document. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.
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